Rise Therapeutics is a clinical-stage biotechnology company focused on the development of innovative immunological therapies. Our team is passionate about transforming lives through science, and we are seeking a dedicated and detail-oriented professional to join our growing clinical operations team.

POSITION SUMMARY:

We are seeking a Data Management Coordinator to manage and oversee clinical trial data within our data management system (Medrio). This individual will ensure the accuracy, integrity, and regulatory compliance of clinical data across development programs, contributing to continuous improvement in data quality and supporting critical decision-making and regulatory submissions.

REQUIRED QUALIFICATIONS:

• Bachelor of Science degree required.
• Minimum 1 year of experience in clinical data management.
• Proven experience with EDC systems (Medrio preferred) and strong understanding of clinical data workflows.
• Working knowledge of FDA/ICH guidelines and clinical trial documents (protocols, SAPs, eCRFs, etc.).
• Ability to manage multiple programs and meet data management milestones.
• Strong communication and collaboration skills across cross-functional teams.

PREFERRED QUALIFICATIONS:

• Experience supporting all phases of clinical development.
• Familiarity with coding standards and external data integration/reconciliation.

• Lead set-up and management of clinical trial data collection systems (EDC, ePRO, and others).
• Oversee data cleaning, validation, and database lock processes, including development of data validation and reconciliation plans.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, and vendors to ensure timely and high-quality data deliverables.
• Act as the primary point of contact with data management vendors, particularly Medrio.
• Conduct and manage data review, query resolution, and preparation for regulatory inspections and submissions.
• Ensure all data management activities are compliant with 21 CFR Part 11 and applicable FDA/ICH regulations.
• Support development of Clinical Outcome Assessment and digital endpoints across therapeutic areas.
• Maintain Data Management Trial Master File (TMF) readiness and documentation archiving.